Edge .04 PP

GUDID 88800069209516

Edge 04 Paper Points 25.04

SURE DENT CORPORATION

Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point Endodontic paper point

• Primary Device ID: 88800069209516
• NIH Device Record Key: 44728538-0ed2-4c35-85b1-e4782abcdd11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Edge .04 PP
• Version Model Number: SPP2504-1
• Company DUNS: 688273010
• Company Name: SURE DENT CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800069209510 [Primary]
GS1	88800069209516 [Unit of Use]

FDA Product Code

• EKN: Point, Paper, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [Edge .04 PP]

• 88800069209813: EDGE X7 04 PAPER POINTS ASSORTED - (20,25,30,35,40,45)
• 88800069209561: Edge 04 Paper Points 50.04
• 88800069209554: Edge 04 Paper Points 45.04
• 88800069209547: Edge 04 Paper Points 40.04
• 88800069209530: Edge 04 Paper Points 35.04
• 88800069209523: Edge 04 Paper Points 30.04
• 88800069209516: Edge 04 Paper Points 25.04
• 88800069209509: Edge 04 Paper Points 20.04
• 88800069209493: Edge 04 Paper Points 15.04